Implementation of Six Sigma as A Quality Control Evaluation of Routine Blood Testing on The Sysmex Xn-1000 Hematology Analyzer
DOI:
10.29303/jppipa.v12i7.15802Published:
2026-07-25Downloads
Abstract
This study aimed to evaluate the analytical performance of routine hematology parameters on the Sysmex XN-1000 Hematology Analyzer using the Six Sigma approach. A quantitative descriptive study with an evaluative design was conducted using secondary internal quality control data collected from the Bandung City Regional Health Laboratory during February–March 2025. The analyzed parameters included hemoglobin (HGB), hematocrit (HCT), leukocytes (WBC), platelets (PLT), and erythrocytes (RBC) at three levels of control materials. Precision was assessed using the coefficient of variation (CV), while accuracy and total allowable error (TEa) were used to calculate sigma metrics. Parameters with sigma values below four were further evaluated using the Quality Goal Index (QGI). The results demonstrated that all parameters had acceptable precision, with CV values below 0.33 TEa, and total error values remained within the allowable limits. Hemoglobin and erythrocyte parameters exhibited excellent analytical performance (5–6 sigma), while leukocyte parameters achieved world-class performance (>6 sigma). Hematocrit and platelet parameters showed good performance (4–5 sigma), whereas several parameters with sigma values below four indicated problems related to imprecision, inaccuracy, or both. The findings indicate that the analytical performance of the Sysmex XN-1000 is generally satisfactory and support the implementation of Sigma Matrix-based quality control strategies to improve laboratory efficiency and reliability.
Keywords:
Analytical performance Clinical laboratory Hematology analyzer Sysmex XN-1000 Six Sigma Quality control Quality Goal IndexReferences
Aarsand, A., Roraas, T., Fernandez-Calle, P., Ricos, C., Díaz-Garzón, J., Jonker, N., ....., & Sandberg, S. (2018). The Biological Variation Data Critical Appraisal Checklist : A Standard for Evaluating Studies on Biological Variation. Clinical Chemistry, 64(3), 501–514. https://doi.org/10.1373/clinchem.2017.281808 DOI: https://doi.org/10.1373/clinchem.2017.281808
Amarni, M., & Dumaidi, K. (2026). Application of Six Sigma , Quality Goal Index , Method Decision Chart , and Operating Specification Metrics as Stringent Quality Control Tools for Assessing the Analytical Performance of BUN , Creatinine , and Glucose. The Journal of Applied Laboratory Medicine, 11(04), 822–831. https://doi.org/10.1093/jalm/jfag043 DOI: https://doi.org/10.1093/jalm/jfag043
Badrick, T., & Theodorsson, E. (2024). Six Sigma – is it time to re-evaluate its value in laboratory medicine ? Clinical Chemistry and Laboratory Medicine (CCLM), 62(12), 2398–2400. https://doi.org/10.1515/cclm-2024-0377 DOI: https://doi.org/10.1515/cclm-2024-0377
Bayat, H., Westgard, S. A., & Westgard, J. O. (2024). The value of Sigma-metrics in laboratory medicine. Clinical Chemistry and Laboratory Medicine (CCLM), 62(12), 2401–2404. https://doi.org/10.1515/cclm-2024-0609 DOI: https://doi.org/10.1515/cclm-2024-0609
Berta, D. M., Melku, M., Adane, T., Girma, M., Mulatie, Z., Chane, E., Teketelew, B. B., Berta, D. M., Melku, M., & Adane, T. (2023). Analytical Performance Evaluation of Hematology Analyzer Using Various TEa Sources and Sigma Metrics Analytical Performance Evaluation of Hematology Analyzer Using Various TEa Sources and Sigma Metrics. Pathology and Laboratory Medicine International, 15(3), 65–75. https://doi.org/10.2147/PLMI.S414693 DOI: https://doi.org/10.2147/PLMI.S414693
Bhatnagar, S., Westgard, S., Dung, N. T. T., Que, T. N., Khanh, B. Q., & Thanh, N. H. (2024). Applying sigma metrics to assess quality control processes in the transfusion transmissible infection screening laboratory of a blood center. PLoS ONE, 9(10), 1–8. https://doi.org/10.1371/journal.pone.0312422 DOI: https://doi.org/10.1371/journal.pone.0312422
Braga, F., Pasqualetti, S., Borrillo, F., Capoferri, A., & Chibireva, M. (2023). De fi nition and application of performance speci fi cations for measurement uncertainty of 23 common laboratory tests : linking theory to daily practice. Clinical Chemistry and Laboratory Medicine (CCLM), 61(2), 213–223. DOI: https://doi.org/10.1515/cclm-2022-0806
Çevlik, T., & Haklar, G. (2024). Six SIGMA evaluation of 17 biochemistry parameters using bias calculated from internal quality control and external quality assurance data. Journal of Medical Biochemistry, 43(1), 43–49. https://doi.org/10.5937/jomb0-43052 DOI: https://doi.org/10.5937/jomb0-43052
Choi, H., Jeong, I., Cheon, J., Park, C., & Min, S. (2025). Application of sigma-based quality control rules for the efficiency of internal quality control. Practical Laboratory Medicine, 47(7), e00501. https://doi.org/10.1016/j.plabm.2025.e00501 DOI: https://doi.org/10.1016/j.plabm.2025.e00501
Dy, P. R., Damian, K. B., & Villanueva, E. Q. (2024). Evaluation of the hematology analyzer test performance using six sigma metrics: A cross sectional study. American Journal of Clinical Pathology, 162, 72–73. https://doi.org/10.1093/ajcp/aqae129 DOI: https://doi.org/10.1093/ajcp/aqae129.162
Giannoli, J., Vassault, A., Carobene, A., Perret, A., Blasutig, I. M., Kumar, P., Lin, J., & Thomas, A. (2025). Clinica Chimica Acta Ensuring internal quality control practices in medical Laboratories : IFCC recommendations for practical applications based on ISO 15189 : 2022. Clinica Chimica Acta, 571(3), 1–15. https://doi.org/10.1016/j.cca.2025.120240 DOI: https://doi.org/10.1016/j.cca.2025.120240
Goswami, P., Anandani, G., & Bhankhodia, V. (2025). Sigma Metric Evaluation of Hematological Parameters : A Retrospective Quality Assessment. 17(9), 8–13. https://doi.org/10.7759/cureus.91375 DOI: https://doi.org/10.7759/cureus.91375
Hens, K., Berth, M., Armbruster, D., & Westgard, S. (2014). Sigma metrics used to assess analytical quality of clinical chemistry assays : importance of the allowable total error ( TEa ) target. Clinical Chemistry and Laboratory Medicine (CCLM), 52(7), 973–980. https://doi.org/10.1515/cclm-2013-1090 DOI: https://doi.org/10.1515/cclm-2013-1090
Hicks, A. J., Carwardine, Z. L., Hallworth, M. J., & Kilpatrick, E. S. (2021). Using clinical guidelines to assess the potential value of laboratory medicine in clinical decision-making. Biochemia Medica, 31(1), 1–11. https://doi.org/https://doi.org/10.11613/BM.2021.010703 DOI: https://doi.org/10.11613/BM.2021.010703
Hu, M., Wang, J., Yang, H., Zang, S., Gao, T., Zeng, J., & Yang, F. (2025). The Application of Six Sigma to Assess the Analytical Performance of Plasma Proteins and Design a Risk- Based Statistical Quality Control Strategy: A Multicenter Study. Journal of Clinical Laboratory Analysis, 39(16), 1–11. https://doi.org/10.1002/jcla.70080 DOI: https://doi.org/10.1002/jcla.70080
Jones, G. R. D., Bell, K. J. L., Ceriotti, F., Loh, T. P., Lord, S., & Sandberg, S. (2024). Applying the Milan models to setting analytical performance specifications–considering all the information. Clinical Chemistry and Laboratory Medicine (CCLM), 62(8), 1531–1537. DOI: https://doi.org/10.1515/cclm-2024-0104
Koshy, J. S., & Raza, A. (2022). Sigma metrics in quality control- An innovative tool. Int J Clin Biochem Res, 8(4), 253–259. https://doi.org/https://doi.org/10.18231/j.ijcbr.2021.055 DOI: https://doi.org/10.18231/j.ijcbr.2021.055
Leite, R., Woodcock, S., Brady, S., Bigsby, C., & Daniel, Y. (2022). Performance analysis of the compact haematology analyser Sight OLO. International Journal of Laboratory Hematology, 44(6), 1078–1087. https://doi.org/10.1111/ijlh.13956 DOI: https://doi.org/10.1111/ijlh.13956
Li, M., Li, X., Lu, X., Zhong, M., Wang, L., & Song, M. (2023). Sigma metric used to evaluate the performance of haematology analysers : choosing an internal reference analyser for the laboratory. Hematology, 28(1), 1–17. https://doi.org/10.1080/16078454.2023.2277498 DOI: https://doi.org/10.1080/16078454.2023.2277498
McCafferty, R., Cembrowski, G., de la Salle, B., Peng, M., & Urrechaga, E. (2024). ICSH guidance for internal quality control policy for blood cell counters. International Journal of Laboratory Hematology, 46(2), 227–233. https://doi.org/10.1111/ijlh.14212 DOI: https://doi.org/10.1111/ijlh.14212
Panteghini, M., & Sandberg, S. (2015). Defining analytical performance specifications 15 years after the Stockholm conference. Clinical Chemistry and Laboratory Medicine (CCLM), 53(6), 829–832. https://doi.org/10.1515/cclm-2015-0303 DOI: https://doi.org/10.1515/cclm-2015-0303
Sandberg, S., Coskun, A., Carobene, A., Fernandez-calle, P., Diaz-garzon, J., Bartlett, W. A., Jonker, N., Galior, K., Gonzales-lao, E., Moreno-parro, I., Sufrate-vergara, B., Webster, C., Aarsand, A. K., & Federation, E. (2024). Analytical performance speci fi cations based on biological variation data – considerations , strengths and limitations. Clinical Chemistry and Laboratory Medicine (CCLM), 62(8), 1483–1489. https://doi.org/10.1515/cclm-2024-0108 DOI: https://doi.org/10.1515/cclm-2024-0108
Sciacovelli, L., Kane, M. O., Skaik, A., Caciagli, P., Rin, G. Da, Ivanov, A., & Plebani, M. (2011). Quality Indicators in Laboratory Medicine: from theory to practice; Preliminary data from the IFCC Working Group Project “Laboratory Errors and Patient Safety.” Clinical Chemistry and Laboratory Medicine, 49(5), 835–844. https://doi.org/10.1515/CCLM.2011.128 DOI: https://doi.org/10.1515/CCLM.2011.128
Westgard, S., Bayat, H., & Westgard, J. O. (2018). Special issue: Six Sigma metrics Review medical laboratories. Biochemia Medica, 28(2), 1–12. https://doi.org/https://doi.org/10.11613/BM.2018.020502 DOI: https://doi.org/10.11613/BM.2018.020502
License
Copyright (c) 2026 Aziz Ansori Wahid, Ally Kafesa, Ni’matul Murtafi’ah, Cep Wahyu
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with Jurnal Penelitian Pendidikan IPA, agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution 4.0 International License (CC-BY License). This license allows authors to use all articles, data sets, graphics, and appendices in data mining applications, search engines, web sites, blogs, and other platforms by providing an appropriate reference. The journal allows the author(s) to hold the copyright without restrictions and will retain publishing rights without restrictions.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in Jurnal Penelitian Pendidikan IPA.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
